FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
71839-127
11-digit product format
718390127
Labeler code
71839
Product ID
71839-127_fb069778-d16e-40f9-9c02-5496adfcb5d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA217521
Marketing category
ANDA
Marketing start
2023-07-10
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenylephrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1232651, 1666372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71839-127-01Phenylephrine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION11
71839-127-25Phenylephrine Hydrochloride25 in 1 CARTONINJECTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-127PHENYLEPHRINE HYDROCHLORIDE INJECTION [BE PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230710_fb069778-d16e-40f9-9c02-5496adfcb5d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNfb069778-d16e-40f9-9c02-5496adfcb5d21
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSNfb069778-d16e-40f9-9c02-5496adfcb5d21
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDfb069778-d16e-40f9-9c02-5496adfcb5d21
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCDfb069778-d16e-40f9-9c02-5496adfcb5d21
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYfb069778-d16e-40f9-9c02-5496adfcb5d21
1232651phenylephrine hydrochloride 1 % Injectable SolutionSYfb069778-d16e-40f9-9c02-5496adfcb5d21
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSYfb069778-d16e-40f9-9c02-5496adfcb5d21
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSYfb069778-d16e-40f9-9c02-5496adfcb5d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71839-127-01718390127011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
71839-127-257183901272525 VIAL, SINGLE-DOSE in 1 CARTON (71839-127-25) / 1 mL in 1 VIAL, SINGLE-DOSE (71839-127-01) 2023-07-10NoNoCurrent